12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KSEA CLEARVISION II, MODEL 40334120
FDA 510(k)
FDA Class 2
·Neurology
Spider Limited Wrist Fusion System
FDA UDI
Smith & Nephew, Inc.·00885556834770·SPIDER 2.4MM SCREW. 10MM L (HEX)
Integra® Spider™ Limted Wrist Fusion System
FDA UDI
Ascension Orthopedics, Inc.·10381780064770·The Integra Spider Limited Wrist Fusion bone sc...
INFINITY HBA KIT, MODELS 537-A, 537-B
FDA 510(k)
FDA Class 2
·Hematology
FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
FDA 510(k)
FDA Class 2
·Physical Medicine
INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·July 15, 2024
MODULAR CATHCART BALL 44MM OD
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LZY·April 23, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2011
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015